Hepatic EchinococcosisICTEHIDANCT04271176
Jaundice as Initial Presentation of Liver Hydatidosis (ICTEHIDA)
An observational study of Hepatic Echinococcosis and Jaundice, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
The aim of this study is to evaluate patients with hepatic hydatidosis whose symptom at diagnosis was obstructive jaundice. As well as analyzing, the rate of performing preoperative ERCP, the results after surgery and morbidity Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Echinococcosis, Jaundice
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2009to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on hydatidic cyst, any surgical option
Who may be able to join
- Hepatic Hydatidosis with obstructive jaundice surgically treated
Who cannot join
- Patients with conservative treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liver Echinococcosis; Jaundice as Initial Presentation, Short and Long Term Results of Surgical Treatment
The aim of this study is to evaluate patients with hepatic hydatidosis whose symptom at diagnosis was obstructive jaundice. As well as analyzing, the rate of performing preoperative ERCP, the results after surgery and morbidity
Read the detailed description
Retrospective study of patients operated on for liver hydatidosis and whose initial symptom was obstructive jaundice Study period: January 2006 to September 2018
The preoperative diagnosis was based on abdominal ultrasound (US), CT scan or magnetic nuclear resonance
Surgical technique Precautions are taken to avoid the spillage of the parasite in the abdominal cavity. The peritoneal cavity is liberally protected with scolicidal agents. All patients have intraoperative ultrasound. Ultrasound is performed to locate the presence of any cysts which might not be seen by the preoperative imaging. Intraoperative ultrasound is also used to find out the relation of the cyst to the big vessels. Depending on the intraoperative findings, the location and size of the cyst will be considered the type of surgery to be performed. Radical surgery (closed and open total cystopericystectomy, or liver resection) or conservative surgery (partial cystopericystectomy, removal of the vesicles with external or internal drainage). When the cyst affects a total lobe and / or the main pedicles, a hepatectomy is performed.
The demographic data of the patients will be taken from their clinical histories. It included age, sex, medical history of hidatidosis, clinical findings, laboratory data, radiological findings, endoscopic treatment, surgical treatment.
The investigators will analyze postoperative mortality and morbidity. Complications' ranking according to the Clavien-Dindo score, 'severe complication' is defined as greater or equal to IIIa
Follow-up The follow-up of these patients will be performed with ultrasound or CT and hydatid serology. The minimum follow-up of the patients is six months. Relapse is defined as the appearance of new active liver cysts after the patient had undergone surgery.
- Conditions
- Hepatic Echinococcosis, Jaundice
- Keywords
- Jaundice, Echinococcosis, Liver, Surgical treatment
- Medical subject headings
- Echinococcosis, Hepatic, Jaundice, Echinococcosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Postoperative morbidity after surgical treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EchinococcosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Badajoz
- Responsible party
- Principal investigator, Gerardo Blanco-Fernández, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271176
- Sponsor's protocol ID
- UE-CHUB 002-2020
- Acronym
- ICTEHIDA
- Status last verified
- Nov 2020
- First submitted
- 12 Feb 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Echinococcosis; Jaundice as Initial Presentation, Short and Long Term Results of Surgical Treatment
- ClinicalTrials.gov ID
- NCT04271176
- Acronym / sponsor ID
- ICTEHIDA / UE-CHUB 002-2020
- Conditions
- Hepatic Echinococcosis, Jaundice
- Keywords
- Jaundice, Echinococcosis, Liver, Surgical treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Badajoz
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate patients with hepatic hydatidosis whose symptom at diagnosis was obstructive jaundice. As well as analyzing, the rate of performing preoperative ERCP, the results after surgery and morbidity
Detailed description
Retrospective study of patients operated on for liver hydatidosis and whose initial symptom was obstructive jaundice Study period: January 2006 to September 2018
The preoperative diagnosis was based on abdominal ultrasound (US), CT scan or magnetic nuclear resonance
Surgical technique Precautions are taken to avoid the spillage of the parasite in the abdominal cavity. The peritoneal cavity is liberally protected with scolicidal agents. All patients have intraoperative ultrasound. Ultrasound is performed to locate the presence of any cysts which might not be seen by the preoperative imaging. Intraoperative ultrasound is also used to find out the relation of the cyst to the big vessels. Depending on the intraoperative findings, the location and size of the cyst will be considered the type of surgery to be performed. Radical surgery (closed and open total cystopericystectomy, or liver resection) or conservative surgery (partial cystopericystectomy, removal of the vesicles with external or internal drainage). When the cyst affects a total lobe and / or the main pedicles, a hepatectomy is performed.
The demographic data of the patients will be taken from their clinical histories. It included age, sex, medical history of hidatidosis, clinical findings, laboratory data, radiological findings, endoscopic treatment, surgical treatment.
The investigators will analyze postoperative mortality and morbidity. Complications' ranking according to the Clavien-Dindo score, 'severe complication' is defined as greater or equal to IIIa
Follow-up The follow-up of these patients will be performed with ultrasound or CT and hydatid serology. The minimum follow-up of the patients is six months. Relapse is defined as the appearance of new active liver cysts after the patient had undergone surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on hydatidic cyst, any surgical option
Key inclusion criteria (1 listed)
- Hepatic Hydatidosis with obstructive jaundice surgically treated
Key exclusion criteria (1 listed)
- Patients with conservative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity
Time frame: 90 days
Postoperative morbidity after surgical treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Echinococcosis and Jaundice, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.